Amplatzer™ 9-ASD-024Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067019301), received between Jul 18, 2018 and Apr 11, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2019Material Deformation; Material Deformation

  ON (B)(6) 2019, A 24MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE THE DEVICE DEPLOYED DEFORMED, COBRA-HEAD SHAPED. THE PROCEDURE WAS COMPLETED WITH A NEW 24MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER UNKNOWN). THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND IS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8503728 ↗
• InjuryAug 21, 2018Material Deformation; Material Deformation

  ON (B)(6) 2018, A 24MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. WHEN THE LEFT DISC WAS DEPLOYED IN THE LEFT ATRIUM, THE DISC DEFORMED. THE DEVICE WAS RE-SHEATHED AND DEPLOYED SEVERAL TIMES WITH THE SAME RESULT. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT COMPLICATION. A SECOND 24MM DEVICE WAS DEPLOYED IN THE LEFT ATRIUM BUT THE LEFT DISC CAME OUT OF THE SHEATH DEFORMED. THE SECOND 24MM DEVICE WAS REMOVED AND A 26MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800968 ↗
• InjuryJul 18, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2018, A 26 MM AMPLATZER ATRIAL SEPTAL OCCLUDER (ASO) WAS SELECTED TO CLOSE AN ATRIAL SEPTAL DEFECT WITH A PEDIATRIC PATIENT. THE 26 MM AMPLATZER ASO WAS FOUND TO BE TOO LARGE SO A 24 MM AMPLATZER ASO WAS IMPLANTED. THERE WAS CONCERN FOR THE 24 MM AMPLATZER ASO DEVICE ON WHETHER OR NOT IT WAS SEATED WELL AND COULD CAUSE POSSIBLE EROSION. ON (B)(6) 2018, THE PATIENT WENT TO THE OPERATING ROOM (OR) TO HAVE THE DEVICE SURGICALLY REMOVED AND DEFECT CLOSED. THE SURGERY WAS SUCCESSFUL AND THE PATIENT IS REPORTED AS STABLE. THE PHYSICIAN STATES THAT THE 24 MM AMPLATZER ASO DEVICE WAS REMOVED DUE TO THE CONCERN OF THE SIZE OF THE DEVICE REQUIRED TO CLOSE THE DEFECT IN RELATION TO THE SMALL SIZE OF THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7699686 ↗